Prescription drug · BLA
Gamifant (Emapalumab-lzsg) NDC 66658-525
Emapalumab 500 mg/20mL · Injection · Intravenous · Swedish Orphan Biovitrum AB (publ)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66658-525-01 | 66658052501 | 1 VIAL, SINGLE-USE in 1 CARTON (66658-525-01) / 20 mL in 1 VIAL, SINGLE-USEMarketed from Jun 7, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Gamifant
- Generic name (nonproprietary)
- emapalumab-lzsg
- Active ingredients
- Emapalumab — 500 mg/20mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Swedish Orphan Biovitrum AB (publ)NDC labeler code 66658
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761107
- Marketing start
- Listing expires
- Other FDA classes
- Interferon gamma Antagonists (Mechanism)
- Identifiers
- Product ID 66658-525_58d52c0a-08fe-40f4-86ba-752dd079ec91SPL ID 58d52c0a-08fe-40f4-86ba-752dd079ec91SPL set ID a865e0ef-8685-4f69-8838-648c4f3bab47RxCUI 2104611, 2104616, 2104621, 2104622, 2380771, 2380772, 2665325, 2665328, 2665330, 2665331, 2665332, 2665333, 2665334, 2665335UNII 3S252O2Z4X
- Pharmacologic class
- Interferon gamma Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N466658052501followed by a unit qualifier and the quantityPackage 66658-0525-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
GAMIFANT is indicated for the treatment of: adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. adult and pediatric patients with HLH/macrophage activation syndrome (MAS) in known or suspected Still’s disease, including systemic Juvenile Idiopathic Arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. GAMIFANT is an interferon gamma (IFNγ) neutralizing antibody indicated for the treatment of: adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive di…
Excerpt only. Read the full label for complete information.
About NDC 66658-525
- What is NDC 66658-525?
- 66658-525 is the product NDC for Gamifant (emapalumab-lzsg), Emapalumab 500 mg/20mL injection, listed with the FDA by Swedish Orphan Biovitrum AB (publ). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gamifant (Emapalumab-lzsg).
- What is the active ingredient?
- Emapalumab.
- Who is the labeler?
- Swedish Orphan Biovitrum AB (publ), NDC labeler code 66658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gamifant?
- 6 other product NDCs are listed under this name. See all Gamifant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gamifant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gamifantemapalumab-lzsg | Emapalumab 50 mg/2mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-522 | 66658-0522-01 |
| Gamifantemapalumab-lzsg | Emapalumab 100 mg/4mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-523 | 66658-0523-01 |
| Gamifantemapalumab-lzsg | Emapalumab 250 mg/10mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-524 | 66658-0524-01 |
| Gamifantemapalumab-lzsg | Emapalumab 100 mg/20mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-510 | 66658-0510-01 |
| Gamifantemapalumab-lzsg | Emapalumab 10 mg/2mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-501 | 66658-0501-01 |
| Gamifantemapalumab-lzsg | Emapalumab 50 mg/10mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-505 | 66658-0505-01 |
Other NDCs under BLA 761107
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gamifantemapalumab-lzsg | Emapalumab 10 mg/2mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-501 |
| Gamifantemapalumab-lzsg | Emapalumab 50 mg/10mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-505 |
| Gamifantemapalumab-lzsg | Emapalumab 100 mg/20mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-510 |
| Gamifantemapalumab-lzsg | Emapalumab 50 mg/2mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-522 |
| Gamifantemapalumab-lzsg | Emapalumab 100 mg/4mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-523 |
| Gamifantemapalumab-lzsg | Emapalumab 250 mg/10mL | InjectionIntravenous | Swedish Orphan Biovitrum AB (publ) | 66658-524 |